FDA Adverse Event
Injury
Summary report: N
ENDOTRACH CONTACT EMG TUBE 6MM
MDR report key: 2895339
·
Received January 3, 2013
Report
- Report Number
- 1045254-2013-00008
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- December 4, 2012
- Report Date
- December 5, 2012
- Manufacturer
- MEDTRONIC XOMED, INC.
- Product Code
- ETN
- PMA / PMN Number
- K925640
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THERE WAS DIFFICULTY VENTING THE PATIENT. THERE WAS A MINOR DELAY IN THE PROCEDURE AS THE EMG TUBE WAS REMOVED AND REPLACED WITH ANOTHER EMG TUBE. THE PATIENT HAD A SORE THROAT AND TEMPORARY HOARSENESS DUE TO RE-INTUBATION. THE PATIENT IS CURRENTLY DOING WELL AND HAS NO ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2505 | ENDOTRACH CONTACT EMG TUBE 6MM | STIMULATOR, NERVE | ETN | MEDTRONIC XOMED, INC. | 8229506 | 0206263569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Required Intervention |